evaluation of the gore® acuseal vascular graft for hemodialysis access

Conditions: End Stage Renal Disease

Summary: this study is a prospective, non-randomized, multi-center evaluation of the performance of the gore® acuseal vascular graft. the study will enroll patients with end-stage renal disease (esrd), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. gore proposes to demonstrate that the 6 month cumulative patency of the gore® acuseal vascular graft is similar to that of other arteriovenous grafts (avgs). \> \>\> \> \>\> a total of 138 subjects will be enrolled. once the study procedure has been successfully completed, cannulation may occur at any time at the investigator's discretion. \> \>\> \> \>\> subjects will be selected from up to 20 investigational sites.


Eligibility criteria:
inclusion criteria:\> 1. patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of end-stage renal disease. \> \>\> 2. patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. \> \>\> 3. the patient must be able to have the vascular access graft placed in an upper extremity. \> \>\> 4. the patient is 18 years of age or older. \> \>\> 5. the patient has a reasonable expectation of remaining on hemodialysis for 12 months. \> \>\> 6. the patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. \> \>\> 7. the patient or his/her legal guardian is willing to provide informed consent. \> \>\> \> \>\> \> \>\> exclusion criteria:\> \>\> 1. the patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.\> \>\> 2. the patient currently has a known or suspected systemic infection.\> \>\> 3. the patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\> \>\> 4. the patient has had a previous instance of heparin induced thrombocytopenia type 2 (hit-2) or has known sensitivity to heparin. \> \>\> 5. the patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.\> \>\> 6. the patient is enrolled in another investigational study.\> \>\> 7. the patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\> \>\> 8. study device is intended to be used temporarily.\> \>\> 9. the patient has had \>2 previous arteriovenous accesses in treatment arm.\> \>\> 10. patient is taking aggrenox®.\> \>\> 11. the patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.\> \>\> 12. the patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(\>10 mg), cyclosporine, tacrolimus or cyclophosphamide.\> \>\> 13. the patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\> \>\> 14. life expectancy is less than 12 months.\> \>\> 15. the patient is pregnant.\> \>\> 16. the patient is a poor compliance risk (i.e. history of iv or oral drug abuse).

Keywords: hemodialysis vascular graft